Archives: Agenda

• Better RFP specifications lead to better proposals, pricing, timelines, and accountability.
• The protocol is not the specification, define the operational assumptions CROs need to price and plan accurately.
• Separate requirements, assumptions, and CRO recommendations so proposals can be compared consistently.
• Standardize bid grids and key assumptions while still allowing CROs to propose differentiated solutions.
• Surface exclusions, dependencies, and hidden assumptions early, these are often the source of future change orders.
• Build uncertainty into the RFP with scenarios for sites, countries, enrollment, timelines, and amendments.
• Use the RFP and bid defense to test how the CRO thinks, not just what they charge.
• Carry proposal commitments into the contract, governance plan, KPIs, and operating model.
• The goal is not simply a better bid, it is better communication, fewer surprises

• Identify protocol risks earlier through integrated clinical, operational and site-level perspectives.
• Design more executable studies by aligning protocol ambition with real-world site and patient needs.
• Reduce avoidable delays, amendments and costs by building feasibility into the protocol from the outset.

Sponsored by EmVenio

• The Adult-Pediatric mediation gap in Immunology
• Barriers to clinical research in children
• How CROs provide solutions to the obstacles of pediatric clinical research

• Bringing the site voice to study design: Partnering with investigators during protocol development to reduce amendments, deviations, and operational friction
• Preventing problems before they happen: Using real-world site feedback to proactively adjust study design and execution
• Acting as the connective driver between sponsor, CRO, and sites to ensure alignment, accountability, and continuity across the trial lifecycle
• Lessons from a lean biotech: Stepping beyond defined roles and filling operational gaps, ensuring data flow and maintaining patient safety
• Redefining success by measuring the unquantifiable impact of strong site relationships on recruitment, retention, and overall trial performance

• Embedding QA from day one: Shifting Quality from a reactive, inspection driven process to proactive design and execution
• Leveraging RBQM frameworks and real time data analytics to anticipate issues, prioritize oversight, and make informed decisions
• Integrating emerging technologies to streamline inspection readiness and improve data integrity
• Applying quality tolerance limits (QTLs), analytics, and cross functional strategies to drive quality forward, reduce deviation risk, and strengthen regulatory confidence
• Delivering future-ready QA practices aligned with ICH expectations to sustain a quality culture

Moderator: Lois Wallace, Senior Manager, Clinical Development, SERB Pharmaceuticals

• Building cross-functional fluency across clinical operations, biometrics, medical affairs and commercial to identify where AI can create value between functions
• Developing boundary-spanning skills by learning enough of each function’s language to translate needs and priorities across teams
• Testing ideas through rapid AI prototyping using LLMs and low-code tools to demonstrate what’s possible
• Partnering across IT, data science and vendors to transform successful prototypes into governed, audit-ready solutions and move from AI-curious to leading an initiative within 90 days

• Strategies for embedding AI tools into everyday workflows and gaining buy-in across cross-functional teams
• Practical lessons for small biotech companies transitioning from experimentation to enterprise-level AI capabilities
• Why data quality, governance, and integrated systems must be established before AI can deliver meaningful insights
• Identifying realistic use cases where AI can support decision-making, forecasting, and operational oversight in drug development